Kornimate/medical-research-clean huggingface dataset:
usefulness of non-invasive pulse co-oximetry haemaglobin measurements in critically ill black patients

Conditions: Critically Ill Black Patients

Summary: to answer the question whether a non-invasive haemaglobin measurement is clinically useful, reliable and accurate as compared to taking a blood sample and checking the haemaglobin level at the laboratory or in a blood gas analyser. this study will take place in a multi-disciplinary icu of critically ill patients.

a presenting sample of 150 patients requiring admission to icu will be enrolled. these will include paediatric, trauma, adult medical and adult surgical patients. informed consent will be obtained. baseline demographic data, vital signs, massey pigmentation score, and severity of illness scores will be calculated, as well as finger deformity, if present, nail polish or acrylics, smoking habits, finger diameter of finger measured, comorbidities and medications. patients will be admitted in the usual way, and admission bloods will be sent to the laboratory as per usual protocol. enrolled patients will in addition have their haemaglobin and plethysmography index (measure of perfusion) measured non-invasively using the masimo pronto-7 handheld device. note of concurrent medications, blood products and vital signs will be recorded at each measurement. each patient will have measurements done 8 hourly (between 1-5 measurements per patient). concurrent arterial blood gas samples will be taken in a heparinised syringe and performed on abl radiometer blood gas analyser.. an additional edta blood sample shall be taken at each pronto measuring point which will be measured at the laboratory on a sysmex cell counter. analysis of data will assess precision and accuracy, trend accuracy, and effect of pigmentation, vasopressors and other medication on the results of the non-invasive co-oximetry estimation of haemaglobin.

Eligibility criteria:
inclusion criteria: * all patients with a condition that requires admission to icu shall be considered to be eligible. * age 1month to 100years old exclusion criteria: * patients under 1 month old * patients with an unrecordable blood pressure or body temperature \<34 degrees.
comparative safety and efficacy evaluation between dermacyd silver and glycerine vegetal soap granado traditional

Conditions: Hygiene

Summary: primary objective: to evaluate the potential of hydratation and renewal of the mucosa, through corneometry measurement and individual questionnaire perception. secondary objective: to evaluate the safety in normal condition of use.


Eligibility criteria:
inclusion criteria: * active sex life * menopause for at least 6 months * perfect mucosa in the evaluated area * use the same cosmetics category exclusion criteria: * use of antiinflammatory / immunosuppression / antihistaminic drugs * personal history of atopy to cosmetic products * cutaneous active disease (local and/or general) in the evaluated area * disease which can cause immunosuppression, such as diabetes, hiv * endocrine pathology such as thyroid disease, ovarian disorder or adrenal gland * intense solar exposure (to get a tan) during the 15 days before the evaluation * gynaecologic treatment until four weeks before the evaluation * whatever vaginal infection detected at time of inclusion * other conditions considered by the investigator as reasonable to exclude the patient from the study the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
symptom screening with targeted early palliative care (step) versus usual care for patients with advanced cancer

Conditions: Cancer

Summary: palliative care is defined as multidisciplinary care that increases quality of life (qol) for patients with a life-threatening illness. although it is known that patients with the most severe physical and psychological symptoms have the greatest need for palliative care, these patients are often not referred to palliative care services in a timely manner. the investigators have developed a system called step (symptom screening with targeted early palliative care) that identifies patients with high symptom burden in order to offer them timely access to palliative care. the investigators are conducting a multi-center trial at princess margaret cancer centre and kingston general hospital to compare step with usual symptom screening in medical oncology clinics.

randomized controlled trials have shown that when patients with advanced cancer were referred early to specialized palliative care teams, they had improved qol, symptom control, and greater satisfaction with their cancer care. such routine specialized palliative care intervention, while effective, may be challenging to enact broadly with widespread shortages of palliative care physicians. step systematically identifies patients with the greatest need, using symptom screening at every outpatient visit, with triage and targeted referral to palliative care. this could reduce resource use while directing care to the most vulnerable. consenting patients from breast, lung, gastrointestinal, genitourinary, and gynecology medical oncology clinics will be assigned randomly either to receive step or to follow usual symptom screening. all patients will complete questionnaires measuring outcomes of qol, symptom control, depression, and satisfaction with care at recruitment, 2, 4 and 6 months. the investigators will measure the impact of step on these outcomes, compared to screening alone.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * diagnosis of stage iv cancer (advanced); hormone-refractory for breast or prostate cancer; stage iii or iv for lung cancer and pancreatic cancer; patients with stage iii cancer and poor clinical prognosis, e.g. ovarian or esophageal cancer, will be included at the discretion of the oncologist * ecog performance status ≤ 2 (estimated by primary oncologist) * prognosis of 6-36 months (estimated by primary oncologist) * patient completes symptom screening in outpatient clinic electronically exclusion criteria: * insufficient english literacy to complete questionnaires * inability of pass the cognitive screening test (somc - short orientation memory concentration test score \ 10 errors) * receiving specialized palliative care within the last 6 months prior to screening, per chart and patient statement.

Keywords: palliative care symptom control quality of life satisfaction with care targeted referral randomized controlled trial
the new silicone n99 half-piece respirator

Conditions: COVID; Personal Protective Equipment

Summary: filter facepiece respirator (ffr) is a critical equipment to prevent the transmission of respiratory tract infection disease especially the dreadful corona virus 2(sars-cov-2).the n95 mask is the prototype of high efficiency protective device and can effectively protect airborne pathogens of less than 0.3 μm by more than 95%. it is tightly fit and had high filtration capacity. the widespread pandemic of covid-19 leads to greater requirement of ffr. a rising in demand would greatly exceed current productive capabilities and stockpiles and would almost certainly result in a robust shortage. in order to solve these problems, our team had invented a new type of half-piece respirator made from silicone and assembled with hepa or elastostatic filter . a variety of methods have been used to evaluate this new device, including qualitative fit test with bitrex® test kit and filtration test.

as required by occupational safety and health administration osha)\[7\], the halfpiece respirators need to pass the fittestto identify those individuals who do not achieve the good fit necessary for adequate protection. the performance of this respirator was also determined by measuring percent leakage under constant airflow\[8\]. the purposes of this study was to evaluate the fitting characteristicof our newly invented silicone n99 respirator and the performance against 30 µm particles using nacl aerosols. the study was conducted to achieve two specific research objectives 1. to investigate the fit characteristic of the novel silicone mask and whether the strap adjustment can help reduce the face-seal leakage 2. to determine the level of performance by measure the inward leakage of the generated aerosolswith the new filter and used filter for up to 24 hours.

Eligibility criteria:
inclusion criteria: * healthcare workers exclusion criteria: * intolerance to exercise * cannot taste bitter sensation

Keywords: respirators n99 covid-19
exercise training using an app on physical cardiovascular function individuals with post-covid-19 syndrome

Conditions: Post-Acute COVID-19 Syndrome

Summary: the aim of this study is to assess the effect of a physical exercise program via a mobile application on functional parameters in individuals with post-covid-19 syndrome. this is a clinical trial involving 60 individuals with post-covid syndrome who will be randomly assigned to either a control group (physical activity guideline) or an experimental group (app-based training).


Eligibility criteria:
inclusion criteria: * laboratory diagnosis of covid-19 * fatigue ≥ 8 points on the chalder scale and/or dyspnea 2-4 on the modified medical research council * have access to a smartphone * have no contraindications for exercise practice * have ability to sit and stand and maintain balance while standing * have preserved cognitive function * have no risk of falls according to the morse fall scale

Keywords: exercise mobile app physical function cardiovascular function
an extension study to demonstrate the equivalence of long-term efficacy and safety of ct-p13 in patients with ankylosing spondylitis who were treated with infliximab (remicade or ct-p13) in study ct-p13 1.1

Conditions: Ankylosing Spondylitis

Summary: this open-label, single-arm, multicenter, multiple single-dose intravenous (iv) infusion, efficacy, and safety extension study of the phase 1 study ct-p13 1.1 is designed to assess the long-term efficacy and safety of multiple doses of ct-p13.


Eligibility criteria:
inclusion criteria: * patient who has completed the scheduled visits, including the end-of-study visit, in study ct-p13 1.1 * patient who has not had any major protocol violation in study ct-p13 1.1 exclusion criteria: * patient who has been withdrawn from study ct-p13 1.1 for any reason * patient who, at the time of providing informed consent, has any ongoing medical issues such as serious adverse events(saes) or intolerance issues that mean continuation in this extension study could be detrimental to their health, in the option of the investigator * patient who plans to participate in a study with an investigational drug during the period of this extension study

Keywords: as biosimilar
study of rofecoxib and prolonged constant infusion of gemcitabine in the polychemotherapy treatment of advanced nsclc

Conditions: Advanced Non-small Cell Lung Cancer

Summary: the purpose of this study is to evaluate the tolerability and efficacy of the addition of rofecoxib to first-line chemotherapy, and to evaluate the efficacy of prolonged continuous infusion of gemcitabine in combination with cisplatin in the treatment of patients affected by advanced non-small cell lung cancer.

the primary end-points of the geco study * to evaluate the tolerability of three innovative schedules of treatment for advanced nsclc * to evaluate the efficacy of the addition of rofecoxib to first-line chemotherapy in the treatment of patients affected by advanced nsclc * to evaluate the efficacy of prolonged continuous infusion (p.c.i.) of gemcitabine, with the fixed infusion rate of 10 mg/sqm/minute) versus the standard administration in 30 minutes, in combination with cisplatin, in the treatment of patients affected by advanced nsclc four treatment arms are planned. * arm a standard treatment : cisplatin + gemcitabine * arm b cisplatin + gemcitabine + rofecoxib * arm c cisplatin + p.c.i. gemcitabine (10 mg/sqm/minute) * arm d cisplatin + p.c.i gemcitabine (10 mg/sqm/minute) + rofecoxib the phase ii part of the study for experimental arms b, c and d will be conducted to evaluate tolerability in the three treatment arms. the phase iii study for efficacy has been designed according to a factorial 2x2 model with the planned comparison of * the efficacy of rofecoxib: a + c (arms without rofecoxib) vs b+d (arms with rofecoxib) * the efficacy of p.c.i. gemcitabine: a + b (arms with standard infusion of gemcitabine) vs c+ d (arms with p.c.i gemcitabine)

Eligibility criteria:
inclusion criteria: * cytologic or histologic diagnosis of non-small cell lung cancer * disease stage iiib or iv * age less than 70 years * ecog performance status 2 or less * patients with cerebral metastases are permitted if they are asymptomatic and do not require radiation therapy concomitant with chemotherapy * negative history of allergy to non-steroidal anti-inflammatory and/or sulphonamide drugs * patients previously treated with radiation therapy are permitted if at least 4 weeks have passed since last therapy * written informed consent exclusion criteria: * previous chemotherapy * previous or concomitant malignant neoplasm (excluding adequately treated baso or spinocellular skin carcinoma or carcinoma in situ of the cervix) * neutrophil \< 2000/mm3, platelets \< 100,000/mm3, haemoglobin \< 10 g/dl * creatinine \> 1.25 x the upper normal limits * got and/or gpt and/or bilirubin \> 1.25 the upper normal limits in absence of hepatic metastases * got and/or gpt and/or bilirubin \> 2.5 the upper normal limits in presence of hepatic metastases * any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study * inability to comply with follow-up

Keywords: prolonged continuous infusion cox-2 inhibitors
home-based proprioceptive neuromuscular facilitation for subjects with type 2 diabetes mellitus

Conditions: Diabetes Mellitus; Exercise

Summary: in this research work, the concept of strengthening technique of proprioceptive neuromuscular facilitation (pnf) incorporated with tendon gliding exercise (tge) will be used to improve neuromuscular function of upper extremity of patients with diabetes mellitus. the first specific aim of the study is to examine the effects of home-based pnf exercise on the motor, sensation and functional performance parameters of upper extremity of the patients with diabetes mellitus. in addition, whether adding a tendon gliding exercise (tge) to the home-based pnf exercises can provide better treatment effects for the patients with diabetes mellitus will also been investigated in this study. one of the hypothesis of this study is the prescribing home-based pnf exercise program has a positive treatment effect on neuromuscular function of the upper extremity of patients with diabetes mellitus. and,the other is home-based pnf in conjunction with tge provides better benefits for neuromuscular function of the upper extremity of patients with diabetes mellitus.


Eligibility criteria:
inclusion criteria: * study participants will include clinically defined diabetic patients who are diagnosed based on the 1997 criteria of the american diabetes association. the inclusion criteria of the enrolled subjects are who suffered from neuropathy as diagnosed by abnormalities in either a nerve conduction study and / or quantitative sensory testing. exclusion criteria: * dm patients with (1) traumatic nerve injuries of the upper limbs, (2) trauma to the hand or congenital anomalies of the wrist and hand, (3) skin infections or disease, (4) known vascular complications of diabetes, such as stroke may have compromised the physical integrity of the patient, (5) grade 2 or higher arterial hypertension (\>160/100 mmhg) or (6) cognitive deficits
safety, tolerability, pharmacokinetics of single rising oral doses of bi 1181181 in healthy male volunteers, including investigation of the effect of food on the bioavailability of bi 1181181

Conditions: Healthy

Summary: to investigate the safety, tolerability, pharmacokinetics (including dose proportionality assessment), and pharmacodynamics of single rising oral doses of bi 1181181 (single rising dose (srd) part) secondly, to investigate the relative bioavailability of the tablet versus the powder for oral solution (pfos) and the effect of food on the pharmacokinetics of bi 1181181 (bioavailability/food effect (ba/fe) part)


Eligibility criteria:
inclusion criteria: * healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs blood pressure (bp), pulse rate (pr), 12-lead ecg, and clinical laboratory tests * age 18 to 50 years (incl.) * body mass index (bmi) 18.5 to 29.9 kg/m2 (incl.) * signed and dated written informed consent prior to admission to the study in accordance with gcp and local legislation exclusion criteria: * any finding in the medical examination (including bp, pr or ecg) deviating from normal and judged clinically relevant by the investigator * repeated measurement of systolic blood pressure \ = 140 mmhg at screening * repeated measurement of diastolic blood pressure \ = 90 mmhg at screening * repeated measurement of pulse rate \ 90 bpm at screening * any laboratory value outside the reference range that the investigator considers to be of clinical relevance * any evidence of a concomitant disease judged clinically relevant by the investigator * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
metabolic syndrome and related diseases in healthcare workers

Conditions: Metabolic Syndrome X; Diabetes Mellitus Type 2; Hypertension; Hyperlipidemia; Obesity; Cardiovascular Diseases; Stroke

Summary: this study aims to investigate the incidence and prevalence of metabolic syndrome and metabolism-related diseases among healthcare workers, identify potential risk factors for these diseases, evaluate the control status of these conditions, and explore the significance of annual regular check-ups in improving metabolic-related health outcomes. all data for the study subjects are sourced from anonymized continuous records in hospital physical examinations and medical case files. the study does not involve any interventions. upon obtaining the study data, researchers will use retrospective analysis methods to identify possible associations between risk factors and diseases.


Eligibility criteria:
inclusion criteria: * age ≥18 years * healthcare workers who attend annual check-ups at peking union medical college hospital exclusion criteria: * presence of metabolic syndrome, hypertension, diabetes, coronary heart disease, or stroke at the time of the first physical examination between 2012 and 2022 * malignant neoplasm * uremia * liver failure * moderate to severe heart failure

Keywords: metabolic syndrome metabolic related diseases medical workers
phase iia double-masked randomized sham-controlled trial of qpi-1007 delivered by a single intravitreal injection to subjects with acute primary angle-closure glaucoma (apacg)

Conditions: Glaucoma, Angle-closure, Primary, Acute

Summary: this study will assess any side effects that may occur when qpi-1007 is injected into the eye in subjects with acute primary angle-closure glaucoma, as well as how long it takes for the body to clear the drug. this study will also test whether qpi-1007, injected into the eye, helps prevent both structural damage of the nerve tissue in the eye and the loss of visual function in subjects with acute primary angle-closure glaucoma.

this is a phase iia double-masked, single dose, randomized, sham-controlled study evaluating the safety and tolerability, and pharmacokinetics of qpi-1007 versus control (sham procedure) in subjects with an acute attack of primary angle-closure glaucoma. subjects will be randomized at a ratio of 1:1 into one of two study arms: 1.5 qpi-1007 arm or control arm (sham procedure). the study will enroll approximately 30 subjects into each arm. randomization will be stratified by time from symptom onset to the study drug administration or sham procedure (≤72 hours and \>72 hours).

Eligibility criteria:
inclusion criteria: * males and females aged at least 40 years or older. * onset of symptoms of an acute attack of primary angle-closure in the study eye within the 120 hours prior to the planned study drug administration. * best-corrected visual acuity (bcva) 20/40 or better in the study eye after resolution of the acute attack. * received successful treatment for the acute attack of angle-closure, and have undergone laser iridotomy with intraocular pressure in the study eye \<25mm hg. * sufficiently clear ocular media and adequate pupil dilation to allow the optic nerve and fovea to be visualized and assessed in the study eye. * female subjects must be: (1) post menopausal, (2) surgically sterile, or (3) using an effective means of contraception. exclusion criteria: * previously diagnosed with glaucoma in either eye. * the time planned for study drug administration is more than 120 hours from the onset of the symptoms. * history of chronic angle-closure in either eye. * secondary angle-closure/secondary angle-closure glaucoma in the study eye. * monocular subjects. * prior incisional intraocular surgery. * inability to perform a reliable visual field test on day 0 in the study eye. * history of panretinal photocoagulation or macular laser photocoagulation in the study eye. * history of active malignancy within the last 5 years (however, non facial, basal cell carcinoma is allowed). * history of myocardial infarction within the last 6 months. * received any drugs known to cause optic nerve or retinal toxicity within 14 days prior to dosing. * women who are pregnant or lactating. * participating in a concurrent interventional study with the last intervention occurring within 30 days prior to planned dosing with qpi-1007.

Keywords: glaucoma, angle-closure glaucoma, closed-angle primary angle closure acute angle closure acute angle-closure glaucoma